Dräger Scio Four, Manual, Page: 15 / 258

Supplement Scio Four modules 15
English
EMC declaration for IEC 60601-1-2, 2nd and 3rd edition
General information
The device was tested for electromagnetic compatibility using
accessories from the list of accessories. Other accessories may
only be used if they do not compromise the electromagnetic com-
patibility. The use of non-compliant accessories may result in
increased electromagnetic emissions or decreased electromag-
netic immunity of the device.
The device may be used in the direct vicinity of other devices only
if Dräger has authorized this device arrangement. If no authoriza-
tion has been given by Dräger, it must be ensured that the device
functions correctly in the desired arrangement before using it. The
instructions for use for the other devices must be followed.
Electromagnetic environment
The medical device is intended for use in an electromagnetic envi-
ronment as specified below. The user must ensure its use in such
an environment.
Rise time (T10...90) <450 ms
Automatic detection
Primary gas At the latest at 0.3 Vol%
Secondary gas At the latest at 0.4 Vol%
With a Desflurane concentration greater than 4 Vol%, mixture detection occurs at
the latest when the concentration of the second anesthetic agent rises above 10 %
of the Desflurane concentration.
The mentioned identification thresholds (primary and secondary) apply to rising agent concentrations (e.g., beginning of an anes-
thetic case).
When anesthetic agent concentration decreases (e.g., end of an anesthetic case), the gas analyzer measures agent concentra-
tions down to 0,05 Vol% based on the last identified agent. Below that value the gas analyzer indicates loss of agent identification
and a value of 0 Vol%.
Respiratory rate (RR)
Range 0 to 100 /min (Respiratory rate is derived from CO
2
real-time data)
Accuracy 0 to 60 /min: ±1 /min with an I:E ratio of 1:1
>60 /min: not specified
0 to 80 /min: ±1 /min with an I:E ratio of 1:2
>80 /min: not specified
Resolution 1 /min
1) The accuracy of the measurement of O
2
, CO
2
, N
2
O and anesthetic agents depends on the respiratory rate and on the I:E ratio. The accuracies of the
expiratory values specified in the technical data apply at a maximum respiratory rate of 60 /min with an I:E ratio of 1:1. The influence of respiratory rate
and I:E ratio on the accuracy has been determined for the measured gas concentrations in a simulated breathing system with step changes in concentra-
tion.
2) The specified accuracy is obtained at the latest 450 seconds after start-up.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1 The medical device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
Class A The medical device is suitable for use in all establishments other
than domestic, and may be used in domestic establishments and
those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes, pro-
vided the following warning is heeded:
Warning: This equipment/system is intended for use by
healthcare professionals only. This equipment/system may
cause radio interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigation
measures, such as re-orienting or relocating the medical
device or shielding the location.
Harmonic emissions
IEC 61000-3-2 Not applicable
Voltage fluctuations/flicker emissions
IEC 61000-3-3 Not applicable